Intermittent claudication
Conditions
Interventions
Trade Name: Pletal
Product Name: Pletal
Pharmaceutical Form: Tablet
Sponsors
Heart of England NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Intermittent claudication as the exercise limiting diagnosis 2. A maximum walking distance of 20-500m (as measured by Treadmill Walking Test) 3. Patient must not have inflow disease requiring intervention 4. Patient must not have any other medical condition that may prevent participation in exercise classes 5. Patient suitable for treatment with cilostazol 6. Patient capable and willing to give fully informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Exercise limited by condition other than intermittent claudication 2. Supra-inguinal arterial disease requiring intervention 3. Presence of other medical condition that may prevent participation in exercise classes 4. Patient having suffered an MI, TIA, CVA or PTCA within 3 months prior to recruitment 5. Patient unsuitable for treatment with cilostazol. Cilostazol treatment is contraindicated in patients: with creatinine clearance rate <25 ml/min with congestive heart failure taking CYP3A4 or CYP2C19 inhibitors (e.g. cimetidine, diltiazem, erythromycin, ketoconazole, lansoprazole, omeprazole and HIV-1 protease inhibitors)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether in patients with mild to moderate intermittent claudication who are amenable to supervised exercise (SEx) and suitable for cilostazol therapy, treatment by: 1. Best medical therapy (BMT) alone 2. BMT + SEx 3. BMT + Cilostazol 4. BMT + SEx + Cilostazol is assocaited with improvement in pain free and absolute walking distance and cost-effective utilisation of NHS resources;Secondary Objective: Patients selected to receive cilostazol therapy will be prescribed cilostazol for a 12 month period after which medication will be withdrawn to investigate the effects of drug withdrawl on pain free and absolute walking distance.;Primary end point(s): Improvement in absolute walking distance Improvement in pain free walking distance Ankle-brachial pressure index Generic and disease-specific health related quality of life Cost-effective utilisation of NHS resources Cardiovascular and all-cause morbidity and mortality | — |
Countries
United Kingdom
Outcome results
None listed